(131 days)
Not Found
No
The summary describes a physical implantable device (a spinal spacer system) and its mechanical testing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is used for intervertebral fusion and vertebral body replacement to treat degenerative disc disease, tumors, or trauma/fracture, aiming to restore spinal stability and height, which are therapeutic actions.
No
Explanation: The device is described as an intervertebral fusion device, a spacer system, and a vertebral body replacement device. Its intended use is for surgical implantation to facilitate spinal fusion or replace vertebral bodies, not to diagnose a medical condition.
No
The device description clearly states that the HONOUR™ Spacer System is a collection of radiolucent cage devices, which are physical implants. The performance studies also describe mechanical testing of these physical devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a surgical implant for spinal fusion and vertebral body replacement. It is used in the body to provide structural support and facilitate bone growth.
- Device Description: The description details a physical implant (radiolucent cage devices) with specific shapes and features for surgical placement.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is a therapeutic implant used inside the body.
N/A
Intended Use / Indications for Use
When used as a cervical intervertebral fusion device, the HONOUR™ devices are indicated for use at one level in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the cervical spine (e.g., the Blade® Anterior Cervical Plate System).
When used as a lumbar intervertebral fusion device, the HONOUR™ devices are indicated for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the lumbar spine (e.g., the Inertia® Pedicle Screw System).
When used as a vertebral body replacement device, the HONOUR™ devices are indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The device is intended for use with autograft or allograft and with supplemental internal fixation systems cleared for use in the thoracolumbar spine (e.g., the Inertia® Pedicle Screw System).
Product codes
MQP, MAX, ODP
Device Description
The HONOUR™ Spacer System is a collection of radiolucent cage devices. The basic shape of these implants is a structural column. The superior and inferior surfaces are open with serrations to facilitate implant stability. The implants are available in an assortment of height, length, width and anteroposterior angulation combinations to accommodate a variety of anatomic requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2-T1), Lumbar spine (L2-S1), Thoracolumbar spine (T1-L5)
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing of the worst case HONOUR spacer was performed according to ASTM F2077 and included static and dynamic compression and static and dynamic torsion. In addition, the subsidence properties were evaluated according to ASTM F2267.
The mechanical test results demonstrate that the HONOUR™ Spacer System devices perform as well as or better than the predicate devices. Hence these devices are as safe and as effective as the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
P960025, K042571, K050624, K061836, K062132, K073470, K082014, K083661, K093704, K091531, K051246, K081177
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
K120 245 Pop 1
JUN 1 3 2012
510(k) Summary
Date:
2 February 2012
Sponsor:
Nexxt Spine LLC 10100 Lantern Road, Ste 200 Fishers. IN 46037 Phone: 317.436.7801 Facsimile: 317.245.2518
Andy Elsbury, President
888.3060 and 888.3080
MQP and MAX/ODP
Contact Person:
HONOUR™ Spacer System Trade Names:
Device Classification Class II
Spinal vertebral body replacement device; Intervertebral fusion Classification Name: device with bone graft, lumbar/cervical
Requiation:
Device Product Codes:
Device Description:
Intended Use:
The HONOUR™ Spacer System is a collection of radiolucent cage devices. The basic shape of these implants is a structural column. The superior and inferior surfaces are open with serrations to facilitate implant stability. The implants are available in an assortment of height, length, width and anteroposterior angulation combinations to accommodate a variety of anatomic requirements.
When used as a cervical intervertebral fusion device, the HONOUR™ devices are indicated for use at one level in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the cervical spine (e.g., the Blade® Anterior Cervical Plate System).
When used as a lumbar intervertebral fusion device, the HONOUR™ devices are indicated for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous graft and with supplemental fixation systems cleared for use in the lumbar spine (e.g., the Inertia® Pedicle Screw System).
When used as a vertebral body replacement device, the HONOUR™ devices are indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the
1
spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The device is intended for use with autograft or allograft and with supplemental internal fixation systems cleared for use in the thoracolumbar spine (e.g., the Inertia® Pedicle Screw System).
Materials:
HONOUR™ Spacers are manufactured from polyetheretherketone (Solvay Zeniva® ZA-500 PEEK) per ASTM F2026. Integral marker pins are manufactured from tantalum according to ASTM F560.
Predicate Devices:
Lumbar I/F Cage® (P960025)
AVS PEEK Spacers (K042571, K050624, K061836, K062132, K073470, K082014, K083661 and K093704)
Stealth™ (K091531)
Construx™ (K051246)
Pillar™ PL/TL (K081177)
Technological Characteristics:
The HONOUR™ Spacer System devices possess the same technological characteristics as the predicate devices. These include:
- intended use (as described above), .
- basic design (hollow structural frame), .
- material (polymer or CFRP), and .
- sizes (widths, lengths and heights are within the range(s) offered . by the predicate systems).
Therefore the fundamental scientific technology of the HONOUR™ Spacer System devices is the same as previously cleared devices.
Performance Data:
Mechanical testing of the worst case HONOUR spacer was performed according to ASTM F2077 and included static and dynamic compression and static and dynamic torsion. In addition, the subsidence properties were evaluated according to ASTM F2267.
The mechanical test results demonstrate that the HONOUR™ Spacer System devices perform as well as or better than the predicate devices. Hence these devices are as safe and as effective as the predicates.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 3 2012
Nexxt Spine, LLC % Backroads Consulting, Inc. Karen Warden, Ph.D. P.O. Box 566 Chesterland, Ohio 44026
Re: K120345
Trade/Device Name: Honour Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: ODP, MAX, MQP Dated: May 16, 2012 Received: May 18, 2012
Dear Dr. Warden:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
3
Page 2 -Karen Warden, Ph.D.
or any Federal statutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Or ic Far 807), abouning (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please rr you attp://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number: K120345
Device Name: HONOUR™ Spacer System
Indications for Use:
When used as a cervical intervertebral fusion device, the HONOUR™ devices are indicated for use at one level in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the cervical spine (e.g., the Blade® Anterior Cervical Plate System).
When used as a lumbar intervertebral fusion device, the HONOUR™ devices are indicated for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the lumbar spine (e.g., the Inertia Pedicle Screw System).
When used as a vertebral body replacement device, the HONOUR™ devices are indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The device is intended for use with autograft or allograft and with supplemental internal fixation systems cleared for use in the thoracolumbar spine (e.g., the Inertia Pedicle Screw System).
Prescription Use X
OR
Over-the-Counter Use_
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Difision of Surgical, Orthopedic, and Restorative Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
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